ANDA 209619

GLAND PHARMA LTD

FDA Drug Application

Application #209619

Application Sponsors

ANDA 209619

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.1% BASE

0

OLOPATADINE HYDROCHLORIDE

OLOPATADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-08-02

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209619
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLOPATADINE HYDROCHLORIDE","activeIngredients":"OLOPATADINE HYDROCHLORIDE","strength":"EQ 0.1% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/02\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/07\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-07
        )

)